Introduction:
A modified prescription-event monitoring (PEM) study was conducted to examine the safety of the introduction of the metered dose inhaler (MDI) Flixotide Evohaler^TM (fluticasone with the propellant HFA 134a)

Methods:
Patients were identified from the first NHS prescriptions dispensed in England for Flixotide Evohaler^TM. Postal questionnaires were sent to the prescribing doctor, requesting information including; demographic characteristics, severity of indication, concomitant medication, event data 3 months prior to and 3 months after the first prescription, and any reasons for stopping Flixotide. Pregnancies, deaths and selected events were followed up. Incidence density ratios (IDRs) were calculated to compare event rates 3 months before and 3 months after the introduction of Flixotide Evohaler^TM.

Results:
The cohort comprised 13413 patients that were prescribed Flixotide Evohaler^TM. The response rate was 64.0%. When the pre- and post-exposure periods were compared fewer patients had events in the post-exposure period, and there was no significant difference in the length of courses of oral steroid use. Eighteen patients experienced an event within 1 hour of using Flixotide Evohaler^TM; these were minor with the exception of one case of angioneurotic facial oedema. Six of these events were assessed as possibly related to Flixotide Evohaler^TM., During the study period there were an additional 13 patients with events assessed as possibly related to Flixotide Evohaler^TM, including two reports of allergic reactions.

Discussion:
The results suggest that the transition to Flixotide Evohaler^TM. was generally well tolerated. The modified methodology has contributed to the risk management of the introduction of this product.